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7. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure‐specific postoperative pain management recommendations.

Author

Anger, M., Valovska, T., Beloeil, H., Lirk, P., Joshi, G. P., Van de Velde, M., Raeder, J., Pogatzki‐Zahn, E, Van de Velde, M, Kehlet, H, Bonnet, F, Rawal, N, Lavand'homme, P, Beloeil, H, Raeder, J, Sauter, A, Albrecht, E, Lirk, P, Freys, S, and Lobo, D

Subjects
*TOTAL hip replacement, *POSTOPERATIVE pain, *PAIN management, *NERVE block, *SPINAL infusions, *FEMORAL nerve, *PAIN measurement
Abstract

Summary: The aim of this systematic review was to develop recommendations for the management of postoperative pain after primary elective total hip arthroplasty, updating the previous procedure‐specific postoperative pain management (PROSPECT) guidelines published in 2005 and updated in July 2010. Randomised controlled trials and meta‐analyses published between July 2010 and December 2019 assessing postoperative pain using analgesic, anaesthetic, surgical or other interventions were identified from MEDLINE, Embase and Cochrane databases. Five hundred and twenty studies were initially identified, of which 108 randomised trials and 21 meta‐analyses met the inclusion criteria. Peri‐operative interventions that improved postoperative pain include: paracetamol; cyclo‐oxygenase‐2‐selective inhibitors; non‐steroidal anti‐inflammatory drugs; and intravenous dexamethasone. In addition, peripheral nerve blocks (femoral nerve block; lumbar plexus block; fascia iliaca block), single‐shot local infiltration analgesia, intrathecal morphine and epidural analgesia also improved pain. Limited or inconsistent evidence was found for all other approaches evaluated. Surgical and anaesthetic techniques appear to have a minor impact on postoperative pain, and thus their choice should be based on criteria other than pain. In summary, the analgesic regimen for total hip arthroplasty should include pre‐operative or intra‐operative paracetamol and cyclo‐oxygenase‐2‐selective inhibitors or non‐steroidal anti‐inflammatory drugs, continued postoperatively with opioids used as rescue analgesics. In addition, intra‐operative intravenous dexamethasone 8–10 mg is recommended. Regional analgesic techniques such as fascia iliaca block or local infiltration analgesia are recommended, especially if there are contra‐indications to basic analgesics and/or in patients with high expected postoperative pain. Epidural analgesia, femoral nerve block, lumbar plexus block and gabapentinoid administration are not recommended as the adverse effects outweigh the benefits. Although intrathecal morphine 0.1 mg can be used, the PROSPECT group emphasises the risks and side‐effects associated with its use and provides evidence that adequate analgesia may be achieved with basic analgesics and regional techniques without intrathecal morphine. [ABSTRACT FROM AUTHOR]

Published
2021
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8. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author

Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, Kraszewski, A, Liang, J, Maguire, J, Mccormick, K, Mcfarlane, K, Mix, C, Modafferi, D, Prathikanti, R, Ryan, C, Santiago, N, Schumacher, J, Seder, C, Shahinfar, S, Soares, B, Stolman, D, Tisher, C, Trotman, M, Tseng, S, Ulias, G, Unger, P, Vyshenskaya, A, Walsh, L, White, C, Wilde, K, Santos, J, Zarazaga, C, Marin, I, Garrote, N, Cusumano, A, Penalba, N, Del Valle, E, Juncos, L, Saye, J, Lef, L, Altobelli, V, Petraglia, G, Rosa-Diez, G, Douthat, W, Lobo, J, Gallart, C, Lafalla, A, Diez, G, Linares, B, Lopez, N, Ramirez, N, Gonzalez, R, Valtuille, R, Beresan, H, Hermida, O, Rudolf, G, Marchetta, N, Rano, M, Ramirez, M, Garcia, N, Gillies, A, Jones, B, Pedagogos, E, Walker, R, Talaulikar, G, Bannister, K, Suranyi, M, Kark, A, Roger, S, Kerr, P, Disney, A, Mount, P, Fraenkel, M, Mathew, M, Fassett, R, Jose, M, Hawley, C, Lonergan, M, Mackie, J, Ferrari, P, Menahem, S, Sabto, J, Hutchison, B, Langham, R, Pollock, C, Holzer, H, Oberbauer, R, Arias, I, Graf, H, Mayer, G, Lhotta, K, Neyer, U, Klauser-Braun, R, Hoerl, W, Horn, S, Kovarik, J, Kramar, R, Eigner, M, Dhaene, M, Billiouw, J, De Meester, J, Warling, X, Cambier-Dwelschauwers, P, Evenepoel, P, Daelemans, R, Dratwa, M, Maes, B, Stolear, J, Dejagere, T, Vanwalleghem, J, Bouman, K, Jadoul, M, Peeters, J, Vanholder, R, Tielemans, C, Donck, J, Almeida, F, de Oliveira, J, Burdmann, E, Garcia, V, Thome, F, Deboni, L, Bregman, R, Lugon, J, Araújo, S, Ferreira Filho, S, Daher Ede, F, Baptista, M, Carvalho, A, D'Avila, D, Moyses Neto, M, Yu, L, Bastos, M, Lacativa, P, Jorgetti, V, Romão Ede, A, da Costa, Jc, Pecoits Filho, R, Gordan, P, Salgado, N, Araújo, M, Coelho, S, Oliveira, I, Moysés, R, Vasconcellos, L, Batista, P, Gross, J, Pedrosa, A, Cournoyer, S, Leblanc, M, Chow, S, Karunakaran, S, Wong, G, Tobe, S, Desmeules, S, Zimmerman, D, Murphy, S, Montambault, P, Donnelly, S, Macrae, J, Culleton, B, Soroka, S, Rabbat, C, Jindal, K, Vasilevsky, M, Michaud, M, Wijeyesinghe, E, Zacharias, J, Lok, C, Muirhead, N, Verrelli, M, Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, Domashenko, O, Gurevich, A, Perlin, D, García, J, Ribes, E, Piera, E, Lucas, M, Galicia, M, Prados, M, González, M, Romero, R, de Francisco, Ám, Montenegro, J, Santiago, C, García, F, de La Ossa, J, Arrieta, J, Pons, J, Martín-Malo, A, Amigó, J, Cases, A, Sterner, G, Jensen, G, Wikström, B, Jacobson, S, Lund, U, Weiss, L, Ståhl, A, von Albertini, B, Burnier, M, Meier, P, Martin, P, Uehlinger, D, Dickenmann, M, Yaqoob, M, Zehnder, D, Kalra, P, Padmanabhan, N, Roe, S, Eadington, D, Pritchard, N, Hutchison, A, Davies, S, Wilkie, M, Davies, M, Pai, P, Swift, P, Kwan, J, Goldsmith, D, Tomson, C, Stratton, J, Dasgupta, I, Sarkar, S, Moustafa, M, Gandhi, K, Jamal, A, Galindo-Ramos, E, Tuazon, J, Batlle, D, Tucker, K, Schiller-Moran, B, Assefi, A, Martinez, C, Samuels, L, Goldman, J, Cangiano-Rivera, J, Darwish, R, Lee, M, Topf, J, Kapatkin, K, Baer, H, Kopelman, R, Acharya, M, Tharpe, D, Bernardo, M, Nader, P, Guzman-Rivera, J, Pergola, P, Sekkarie, M, Alas, E, Zager, P, Liss, K, Navarro, J, Roppolo, M, Denu-Ciocca, C, Kshirsagar, A, El Khatib, M, Kant, K, Scott, D, Murthyr, B, Finkelstein, F, Keightley, G, Mccrary, R, Pitone, J, Cavalieri, T, Tsang, A, Pellegrino, B, Schmidt, R, Ahmad, S, Brown, C, Friedman, E, Mittman, N, Fadem, S, Shapiro, W, Reddy, M, Goldberger, S, Woredekal, Y, Agarwal, A, Anger, M, Haque, M, Chidester, P, Kohli, R, Rubinstein, S, Newman, G, Gladish, R, Ayodeji, O, Soman, S, Sprague, S, Hunt, N, Gehr, T, Rizk, D, Warnock, D, Polack, D, Pahl, M, Fischer, D, Dreyer, P, James, G, Husserl, F, Rogers, T, Raff, A, Sedor, J, Silver, M, Smith, M, Steinberg, S, Delgiorno, T, Jones, E, Cunha, P, Cheng, J, Pogue, V, Blumenthal, S, Brown, E, Charytan, C, Buerkert, J, Cook, M, Felsenfeld, A, Tareen, N, Gupta, A, Herman, T, Diamond, S, Hura, C, Laski, M, Maclaurin, J, Plumb, T, Brosnahan, G, Kumar, J, Henriquez, M, Poole, C, Osanloo, E, Matalon, A, Sholer, C, Arfeen, S, Azer, M, Belledonne, M, Gross, M, Dunnigan, E, Mcconnell, K, Becker, B, Rigolosi, R, Spiegel, D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.

Subjects
Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract

Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).

Published
2012
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9. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author

Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., Hannedouche T., Vela C., Lionet A., Ryckelynck P., Zaoui P., Choukroun G., Fessi H., Lang P., Stroumza P., Joly D., Mousson C., Laville M., Dellanna F., Erley C., Braun J., Rambausek M., Riegel W., Klingberg M., Schwertfeger E., Wizemann V., Eckardt K., Reichel H., Passauer J., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., Kulcsar I., Mezei I., Csiky B., Rikker C., Arkossy O., Berta K., Szegedi J., Major L., Ferenczi S., Fekete A., Szabo T., Zakar G., Wagner G., Kazup Erdelyine S., Borbas B., Eustace J., Reddan D., Capasso G., Locatelli F., Villa G., Cozzolino M., Brancaccio D., Messa P., Bolasco P., Ricciardi B., Malberti F., Moriero E., Cannella G., Ortalda V., Stefoni S., Frasca G., Cappelli G., Albertazzi A., Zoccali C., Farina M., Elli A., Avella F., Ondei P., Mingardi G., Errico R., Losito A., Di Giulio S., Pertosa G., Schena F., Grandaliano G., Gesualdo L., Auricchio M., Bochicchio-Ricardelli T., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak Gregoor P., Hagen E., Van Der Sande F., Klinger M., Nowicki M., Muszytowski M., Bidas K., Bentkowski W., Wiecek A., Ksiazek A., Marczewski K., Ostrowski M., Switalski M., Sulowicz W., Matuszkiewicz-Rowinska J., Mysliwiec M., Durlik M., Rutkowski B., Macario F., Carvalho B., Frazao J., Machado D., Weigert A., Andrusev A., Khrustalev O., Zemtchenkov A., Gurevich K., Staroselsky K., Khadikova N., Rozhinskaya L., Timokhovskaya G., Strokov A., Balkarova O., Ermolenko V., Kolmakova E., Komandenko M., Timofeev M., Shilo V., Shostka G., Smirnov A., Anashkin V., Volgina G., Domashenko O., Gurevich A., Perlin D., Martinez Garcia J., Andres Ribes E., Coll Piera E., Fernandez Lucas M., Galicia M., Prados M., Gonzalez M., Romero R., Martin de Francisco A., Montenegro J., Santiago C., Garcia F., Alcazar De La Ossa J., Arrieta J., Pons J., Martin-Malo A., Soler Amigo J., Cases A., Sterner G., Jensen G., Wikstrom B., Jacobson S., Lund U., Weiss L., Stahl A., Von Albertini B., Burnier M., Meier P., Martin P., Uehlinger D., Dickenmann M., Yaqoob M., Zehnder D., Kalra P., Padmanabhan N., Roe S., Eadington D., Pritchard N., Hutchison A., Davies S., Wilkie M., Davies M., Pai P., Swift P., Kwan J., Goldsmith D., Tomson C., Stratton J., Dasgupta I., Sarkar S., Moustafa M., Gandhi K., Jamal A., Galindo-Ramos E., Tuazon J., Batlle D., Tucker K., Schiller-Moran B., Assefi A., Martinez C., Samuels L., Goldman J., Cangiano-Rivera J., Darwish R., Lee M., Topf J., Kapatkin K., Baer H., Kopelman R., Acharya M., Tharpe D., Bernardo M., Nader P., Guzman-Rivera J., Pergola P., Sekkarie M., Alas E., Zager P., Liss K., Navarro J., Roppolo M., Denu-Ciocca C., Kshirsagar A., El Khatib M., Kant K., Scott D., Murthyr B., Finkelstein F., Keightley G., McCrary R., Pitone J., Cavalieri T., Tsang A., Pellegrino B., Schmidt R., Ahmad S., Brown C., Friedman E., Mittman N., Fadem S., Shapiro W., Reddy M., Goldberger S., Woredekal Y., Agarwal A., Anger M., Haque M., Chidester P., Kohli R., Rubinstein S., Newman G., Gladish R., Ayodeji O., Soman S., Sprague S., Hunt N., Gehr T., Rizk D., Warnock D., Polack D., Pahl M., Fischer D., Dreyer P., James G., Husserl F., Rogers T., Raff A., Sedor J., Silver M., Smith M., Steinberg S., DelGiorno T., Jones E., Cunha P. D., Cheng J., Pogue V., Blumenthal S., Brown E., Charytan C., Buerkert J., Cook M., Felsenfeld A., Tareen N., Gupta A., Herman T., Diamond S., Hura C., Laski M., MacLaurin J., Plumb T., Brosnahan G., Kumar J., Henriquez M., Poole C., Osanloo E., Matalon A., Sholer C., Arfeen S., Azer M., Belledonne M., Gross M., Dunnigan E., McConnell K., Becker B., Skinner F., Rigolosi R., Spiegel D., Stegman M., Patak R., Streja D., Ranjit U., Youell T., Wooldridge T., Stafford C., Cottiero R., Weinberg M., Schonefeld M., Shahmir E., Hazzan A., Ashfaq A., Bhandari K., Cleveland W., Culpepper M., Golden J., Lai L., Lien Y., Lorica V., Robertson J., Malireddi K., Morse S., Thakur V., Israelit A., Raguram P., Alfred H., Weise W., Al-Saghir F., El Shahawy M., Rastogi A., Nissenson A., Kopyt N., Lynn R., Lea J., McClellan W., Teredesai P., Ong S., Tolkan S., Sugihara J., Minga T., Mehrotra R., Minasian R., Bhatia D., Specter R., Capelli J., Sidhu P., Dalal S., Dykes P., Khan M., Rahim F., Saklayen M., Thomas A., Michael B., Torres M., Al-Bander H., Murray B., Abukurah A., Gupta B., Nosrati S., Raja R., Zeig S., Braun M., Amatya A., Endsley J., Sharon Z., Dolson G., Dumler F., Ntoso K., Rosansky S., Kumar N., Gura V., Thompson N., Goldfarb D., Halligan R., Middleton J., Widerhorn A., Arbeit L., Arruda J., Crouch T., Friedman L., Khokhar S., Mittleman J., Light P., Taparia B., West C., Cotton J., Dhingra R., Kleinman L., Arif F., Lew S., Nammour T., Sterrett J., Williams M., Ramirez J., Rubin J., McCarthy J., Noble S., Chaffin M., Rekhi A., Moe, S. M., Chertow, G. M., Parfrey, P. S., Kubo, Y., Block, G. A., Correa-Rotter, R., Drueke, T. B., Herzog, C. A., London, G. M., Mahaffey, K. W., Wheeler, D. C., Stolina, M., Dehmel, B., Goodman, W. G., Floege, J., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., Van Der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences

Subjects
Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract

Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.

Published
2015

11. Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease

Author

De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., McMurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., McCullough, P., Ivanovich, P., Ketteler, M., Lachin, J., McGill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., McMahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, DS., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., LeBeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., Mcmurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., Mccullough, P., Ivanovich, P., Ketteler, M., Lachin, J., Mcgill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., Mcmahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, Ds., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., Lebeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., de Zeeuw, D, Akizawa, T, Audhya, P, Bakris, Gl, Chin, M, Christ Schmidt, H, Goldsberry, A, Houser, M, Krauth, M, Lambers Heerspink, Hj, Mcmurray, Jj, Meyer, Cj, Parving, Hh, Remuzzi, G, Toto, Rd, Vaziri, Nd, Wanner, C, Wittes, J, Wrolstad, D, Chertow, Gm, Pisani, Antonio, De Zeeuw, D, Bakris, G, Lambers Heerspink, H, Mcmurray, J, Meyer, C, Parving, H, Toto, R, Vaziri, N, and Chertow, G.

Subjects
Male, medicine.medical_specialty, Intention to Treat Analysi, NF-E2-Related Factor 2, NEPHROPATHY, Urology, Renal function, Kaplan-Meier Estimate, Type 2 diabetes, Placebo, Article, Nephropathy, NRF2, Double-Blind Method, Cardiovascular Disease, Diabetes mellitus, Internal medicine, medicine, CKD, Treatment Failure, Bardoxolone methyl, Oleanolic Acid, Renal Insufficiency, Chronic, Aged, OUTCOMES, IRBESARTAN, ANALOGS, business.industry, Medicine (all), Hazard ratio, General Medicine, Middle Aged, medicine.disease, Weight Lo, Endocrinology, Diabetes Mellitus, Type 2, Diabetic Nephropathie, Kidney Failure, Chronic, Female, TRIAL, Stage 4 chronic kidney disease, business, Glomerular Filtration Rate, Human, RENAL EVENTS BEACON
Abstract

Background: Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)–related factor 2 activators further reduce this risk is unknown. Methods: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to < 30 ml per minute per 1.73 m2 of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. Results: The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P < 0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. Conclusions: Among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease, bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. A higher rate of cardiovascular events with bardoxolone methyl than with placebo prompted termination of the trial. (Funded by Reata Pharmaceuticals; BEACON ClinicalTrials.gov number, NCT01351675.)

Published
2013

12. Full and Booster Doses of SARS-CoV-2 mRNA-1273 Vaccine Increase Waning Antibody Levels After Completed Vaccination Among Dialysis Patients at a Large Dialysis Organization

Author

Ficociello LH, Willetts J, Mullon C, Johnson C, Anger MS, and Hymes JL

Subjects
dialysis · covid-19 · vaccination · antibody · mrna-1273 vaccine · booster, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Linda H Ficociello,1 Joanna Willetts,1 Claudy Mullon,1 Curtis Johnson,2 Michael S Anger,1 Jeffrey L Hymes1 1Global Medical Office, Fresenius Medical Care, Waltham, MS, USA; 2Spectra Laboratories, Southaven, MS, USACorrespondence: Jeffrey L Hymes, Fresenius Medical Care, 1000 Corporate Centre Drive, Suite 400, Franklin, TN, 37067, USA, Email Jeffrey.HymesMD@freseniusmedicalcare.com

Published
2022

13. Serum Phosphorus and Pill Burden Among Hemodialysis Patients Prescribed Sucroferric Oxyhydroxide: One-Year Follow-Up on a Contemporary Cohort

Author

Kendrick JB, Zhou M, Ficociello LH, Parameswaran V, Mullon C, Anger MS, and Coyne DW

Subjects
sucroferric oxyhydroxide, hemodialysis, pill burden, serum phosphorus, phosphate binder, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Jessica B Kendrick,1 Meijiao Zhou,2 Linda H Ficociello,2 Vidhya Parameswaran,2 Claudy Mullon,2 Michael S Anger,2,3 Daniel W Coyne4 1University of Colorado Anschutz Medical Campus, Aurora, CO, USA; 2Fresenius Medical Care Global Medical Office, Waltham, MA, USA; 3Unversity of Colorado School of Medicine, Denver, CO, USA; 4Washington University School of Medicine, St. Louis, MO, USACorrespondence: Daniel W Coyne, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA, Tel +1 314-362-7603, Fax +1 314-747-5213, Email dcoyne@wustl.eduPurpose: In prior analyses of real-world cohorts of hemodialysis patients switched from one phosphate binder (PB) to sucroferric oxyhydroxide (SO), SO therapy has been associated with improvements in serum phosphorus (sP) and reductions in daily PB pill burden. To characterize how SO initiation patterns have changed over time, we examined the long-term effectiveness of SO in a contemporary (2018– 2019) cohort.Patients and Methods: Adult Fresenius Kidney Care hemodialysis patients first prescribed SO monotherapy as part of routine care between May 2018 and May 2019 (N = 1792) were followed for 1 year. All patients received a non-SO PB during a 91-day baseline period before SO prescription. Mean PB pills/day and laboratory parameters were compared before and during SO treatment. Results were divided into consecutive 91-day intervals (Q1–Q4) and analyzed using linear mixed-effects regression and Cochran’s Q test. These results were contrasted with findings from a historical (2014– 2015) cohort (N = 530).Results: The proportion of patients achieving sP ≤ 5.5 mg/dl increased after switching to SO (from 27.0% at baseline to 37.8%, 45.1%, 44.7%, and 44.0% at Q1, Q2, Q3, and Q4, respectively; P < 0.0001 for all). The mean daily PB pill burden decreased from a baseline of 7.7 to 4.4, 4.6, 4.8, and 4.9, respectively, across quarters (P < 0.0001 for all). Patients in the contemporary cohort had improved sP control (27.0% achieving sP ≤ 5.5 mg/dl vs 17.7%) and lower daily PB pill burden (mean 7.7 vs 8.5 pills/day) at baseline than those in the historical cohort. Overall use of active vitamin D was similar between cohorts, although higher use of oral active vitamin D (63.9% vs 15.7%) and lower use of IV active vitamin D lower (23.4% vs 74.2%) was observed in the contemporary cohort.Conclusion: Despite evolving treatment patterns, switching to SO resulted in improved sP control with fewer pills per day in this contemporary hemodialysis cohort.Keywords: sucroferric oxyhydroxide, hemodialysis, pill burden, serum phosphorus, phosphate binder

Published
2022

14. Regards croisés sur le cœur artificiel : l’application in concretodes droits des malades

Author

Moquet-Anger, M.-L.

Abstract

Les techniques de chirurgie cardiaque obligent le juriste, après avoir évoqué les règles et principes juridiques applicables, à envisager leur mise en œuvre dans des situations complexes et tendues tant du fait de la haute technicité des actes de soins prodigués, que des enjeux éthiques, philosophiques et moraux auxquels sont exposés les malades, mais aussi les familles ou leurs proches, sans oublier les personnels médicaux et soignants. La présente étude propose d’analyser comment les droits du malade, mais aussi par effet de miroir et en cherchant à les concilier, les devoirs des professionnels de santé, peuvent être mis en œuvre, notamment lorsque le recours au cœur artificiel semble être la réponse médicale au traitement du patient. Le recours dans un premier temps à l’ECMO, puis à une assistance cardiaque de longue durée mettent en exergue, d’une part, la question de l’acceptabilité par le patient du potentiel passage du corps humain à la machine humaine et, d’autre part, l’acceptation du renoncement à des chances de survie tant par le patient que l’équipe médicale. Autrement dit, il s’agit d’examiner la manière dont le droit appréhende la décision médicale du recours à ces technologies et le refus ou l’impossibilité d’en bénéficier.

Published
2024
Full Text
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15. Effect of Citrate-Acidified Dialysate on Intact Parathyroid Hormone in Prevalent Hemodialysis Patients: A Matched Retrospective Cohort Study

Author

Ficociello LH, Zhou M, Mullon C, Anger MS, and Kossmann RJ

Subjects
hemodialysis, citrate-acidified dialysate, acetate-acidified dialysate, parathyroid hormone, ipth, serum calcium, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Linda H Ficociello,1 Meijiao Zhou,1 Claudy Mullon,1,2 Michael S Anger,1,2 Robert J Kossmann1 1Fresenius Medical Care, Global Medical Office, Waltham, MA, USA; 2Fresenius Medical Care, Renal Therapies Group, Waltham, MA, USACorrespondence: Robert J Kossmann Email Robert.Kossmann@fmc-na.comBackground: It has been proposed that substituting citrate-acidified dialysate (CAD) solutions for acetate-acidified dialysate (AAD) could improve hemodynamics and dialysis tolerance and reduce the requirement for systemic anticoagulation. Citrate chelates ionized calcium, but long-term effects of CAD use during maintenance hemodialysis have not been well studied. While many studies of the effects of CAD on serum calcium and intact parathyroid hormone (iPTH) have been short-term or have been limited by sample size, we aimed to determine if there are any long-term (i.e., 6-month) changes from pre-dialysis iPTH levels when patients are switched from AAD to CAD.Methods: This retrospective cohort study compared various clinical parameters, including pre-dialysis iPTH and serum calcium as well as single pool Kt/V, from eligible patients who received in-center hemodialysis thrice-weekly in geographically matched CAD (n=3) or AAD clinics (n=12). CAD clinics were defined as clinics converting from AAD to CAD if > 85% of the patients were prescribed CAD after implementation of CAD within the clinic.Results: Pre-dialysis iPTH was not significantly different from baseline to 6-month follow-up within either CAD or AAD clinics. Moreover, the mean change from baseline to month 6 in iPTH between patients (n=142) in CAD clinics (− 17 pg/mL) and patients (n=671) in AAD clinics (13 pg/mL) was similar (p = 0.24). Likewise, the differences in the mean change in serum calcium concentrations and dialysis adequacy (single pool Kt/V) were not significant between CAD and AAD clinics. For subgroups of patients who were never prescribed cinacalcet or calcium-based phosphate binders, there were no significantly different categorical shifts in iPTH between CAD and AAD clinics.Conclusion: Similar trends in single pool Kt/V, iPTH, and serum calcium levels were observed in clinics that switched from AAD to CAD versus the geographically matched AAD clinics. These results support CAD as a potential alternative to AAD in hemodialysis.Keywords: hemodialysis, citrate-acidified dialysate, acetate-acidified dialysate, parathyroid hormone, iPTH, serum calcium

Published
2021

17. Slipping Through the Pores: Hypoalbuminemia and Albumin Loss During Hemodialysis

Author

Kalantar-Zadeh K, Ficociello LH, Bazzanella J, Mullon C, and Anger MS

Subjects
dialysis membrane, dialyzer, nutrition, hemodialysis, protein-energy wasting, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Kamyar Kalantar-Zadeh,1– 3 Linda H Ficociello,4 Jennifer Bazzanella,5 Claudy Mullon,4 Michael S Anger4 1Division of Nephrology, Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine, Orange, CA, USA; 2Department of Epidemiology, University of California, Los Angeles (UCLA), Los Angeles, CA, USA; 3Los Angeles Biomedical Research Institute at Harbor–UCLA, Torrance, CA, USA; 4Fresenius Medical Care Renal Therapies Group, Waltham, MA, USA; 5Fresenius Kidney Care, Madison, WI, USACorrespondence: Kamyar Kalantar-ZadehDivision of Nephrology, Hypertension and Kidney Transplantation, University of California, Irvine Medical Center, 101 the City Drive South, Orange, CA 92868-3217, USATel +1-714-456-5142Fax +1-714-456-6034Email kkz@uci.eduAbstract: Hypoalbuminemia results when compensatory mechanisms are unable to keep pace with derangements in catabolism/loss and/or decreased synthesis of albumin. Across many disease states, including chronic kidney disease (CKD), hypoalbuminemia is a well-established, independent risk factor for adverse outcomes, including mortality. In the setting of CKD, reduced serum albumin concentrations are often a manifestation of protein-energy wasting, a state of metabolic and nutritional alterations resulting in reduced protein and energy stores. The progression of CKD to kidney failure and the initiation of maintenance hemodialysis (HD) further predisposes an already at-risk population toward hypoalbuminemia such that approximately 60% of HD patients have albumin concentrations < 4.0 g/dl. Albumin loss into the dialysate through the dialyzer appears to be a potentially modifiable cause of hypoalbuminemia in some patients. A group of newer dialyzers for maintenance HD—sometimes termed protein-leaking or medium cut-off membranes—aim to improve clearance of middle molecules (vs high flux dialyzers) but are associated with increased albumin losses. In this article, we will examine the impact of dialyzer selection on albumin losses during conventional HD, including the clinical relevance of such losses on serum albumin levels. Data on the clinical relevance of albumin losses during dialysis and current gaps in the evidence base are also discussed.Keywords: dialysis membrane, dialyzer, nutrition, hemodialysis, protein-energy wasting

Published
2021

20. Cell cycle synchronization of porcine fetal fibroblasts: Effects of serum deprivation and reversible cell cycle inhibitors

Author

Wilfried Kues, Anger, M., Carnwath, J. W., Paul, D., Motlik, J., Niemann, H., and Publica

Subjects
Serum, Aphidicolin, Broxuridine, Swine, Messenger RNA, genetic transcription, Butyrolactone, cell cycle, protein kinase, animal cell culture, fibroblast
Abstract

The success of somatic nuclear transfer critically depends on the cell cycle stage of the donor nucleus and the recipient cytoplast. In this study we tested serum deprivation as well as two reversible cell cycle inhibitors, aphidicolin and butyrolactone I, for their ability to synchronize porcine fetal fibroblasts at either G0 stage or G1/S or G2/M transition. The synchronization efficiency of the various protocols was determined by fluorescence-activated cell sorting (FACS), cell proliferation assays, and semiquantitative multiplex reverse transcription-polymerase chain reaction detection of the cell cycle-regulated porcine Polo-like kinase mRNA (Plk-p). FACS measurements revealed that 66.6-73.3% of the porcine fetal fibroblasts were in G0/G1 stage (2C DNA content) in serum-supplemented medium. Short periods of 24-72 h of serum deprivation significantly increased the proportion of cells at G0/G1 phase to 77.9-80.2%, and mitotic activity had already terminated after 48 h. Prolonged culture in serum-deprived medium induced massive DNA fragmentation. Aphidicolin treatment led to an accumulation of 81.9 +/- 4.9% of cells at the G1/S transition. Butyrolactone I arrested 81.0 +/- 5.8% of the cells at the end of G1 stage and 37.0 +/- 6.8% at the G2/M transition. The effects of both chemical inhibitors were fully reversible, and their removal led to a rapid progression in the cell cycle. The measurement of Plk-p expression allowed discrimination between the presumptive G0 phase induced by serum deprivation and the G1/S transition arrest achieved by chemical inhibitors. These data indicate that porcine fetal fibroblasts can be effectively synchronized at various cell cycle stages without compromising their proliferation capacity.

Published
2000

22. Role of cleavage by separase of the Rec8 kleisin subunit of cohesin during mammalian meiosis I

Author

Kudo, N.R., Anger, M., Peters, A., Stemmann, O., Theussl, H.C., Helmhart, W., Kudo, H., Heyting, C., Nasmyth, K., Kudo, N.R., Anger, M., Peters, A., Stemmann, O., Theussl, H.C., Helmhart, W., Kudo, H., Heyting, C., and Nasmyth, K.

Abstract

Proteolytic activity of separase is required for chiasma resolution during meiosis I in mouse oocytes. Rec8, the meiosis-specific alpha-kleisin subunit of cohesin, is a key target of separase in yeast. Is the equivalent protein also a target in mammals? We show here that separase cleaves mouse Rec8 at three positions in vitro but only when the latter is hyper-phosphorylated. Expression of a Rec8 variant (Rec8-N) that cannot be cleaved in vitro at these sites causes sterility in male mice. Their seminiferous tubules lack a normal complement of 2 C secondary spermatocytes and 1 C spermatids and contain instead a high proportion of cells with enlarged nuclei. Chromosome spreads reveal that Rec8-N expression has no effect in primary spermatocytes but produces secondary spermatocytes and spermatids with a 4 C DNA content, suggesting that the first and possibly also the second meiotic division is abolished. Expression of Rec8-N in oocytes causes chromosome segregation to be asynchronous and delays its completion by 2-3 hours during anaphase I, probably due to inefficient proteolysis of Rec8-N by separase. Despite this effect, chromosome segregation must be quite accurate as Rec8-N does not greatly reduce female fertility. Our data is consistent with the notion that Rec8 cleavage is important and probably crucial for the resolution of chiasmata in males and females

Published
2009

23. Resolution of chiasmata in oocytes requires separase-mediated proteolysis.

Author

Kudo, N.R., Wassmann, K., Anger, M., Schuh, M., Wirth, K.G., Xu, H., Helmhart, W., Kudo, H., McKay, M.J., Maro, B., Ellenberg, J., Boer, P. de, Nasmyth, K., Kudo, N.R., Wassmann, K., Anger, M., Schuh, M., Wirth, K.G., Xu, H., Helmhart, W., Kudo, H., McKay, M.J., Maro, B., Ellenberg, J., Boer, P. de, and Nasmyth, K.

Abstract

Contains fulltext : 50332.pdf (publisher's version ) (Closed access)

Published
2006

24. Molding and replication of ceramic surfaces with nanoscale resolution

Author

Anger, M. A., Schilardi, P. L., Caretti, Ignacio, Sánchez, Olga, Benítez, G., Albella, J. M., Gago, Raúl, Fonticelli, Mariano, Vázquez, Luis, Salvarezza, R. C., Azzaroni, O., Anger, M. A., Schilardi, P. L., Caretti, Ignacio, Sánchez, Olga, Benítez, G., Albella, J. M., Gago, Raúl, Fonticelli, Mariano, Vázquez, Luis, Salvarezza, R. C., and Azzaroni, O.

Abstract

The design of reproducible and more efficient nanofabrication routes has become a very active research field in recent years. In particular, the development of new methods for micro- and nanopatterning materials surfaces has attracted the attention of many researchers in industry and academia as a consequence of the growing relevance of patterned surfaces in many technological fields, ranging from optoelectronics to biotechnology. In this work we explore, discuss, and demonstrate the possibility of extending the well-known molding and replication strategy for patterning ceramic materials with nanoscale resolution. To achieve this goal we have combined physical deposition methods, molecule-thick anti-sticking coatings, and nanostructured substrates as master surfaces. This new perspective on an >old technology>, as molding is, provides an interesting alternative for high-resolution, direct surface-relief patterning of materials that currently requires expensive and time-consuming lithographic approaches. © 2005 Wiley-VCH Verlag GmbH & Co. KGaA.

Published
2005

25. Prospective memory in autism spectrum disorder

Author

Bensaber, F., primary, Gonneaud, J., additional, Bon, L., additional, Hamel-Desbruères, A., additional, Anger, M., additional, Guénolé, F., additional, Eustache, F., additional, Baleyte, J.M., additional, Desgranges, B., additional, and Guillery-Girard, B., additional

Published
2012
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39. Nitrous oxide emissions from artificial urine patches applied to different N-fertilized swards and estimated annual N2O emissions for differently fertilized pastures in an upland location in Germany.

Author

Anger, M., Hoffmann, C., and Kühbauch, W.

Subjects
SOIL composition, NITRATES, NITROUS oxide, NITROGEN fertilizers, PASTURES, UPLANDS
Abstract

Artificial urine containing 20.2 g N per patch of 0.2 m² was applied in May and September to permanent grassland swards of a long-term experiment in the western uplands of Germany (location Rengen/Eifel), which were fertilized with 0, 120, 240, 360 kg N ha-1 yr-1 given as calcium ammonium nitrate. The effect on N2O fluxes measured regularly during a 357-day period with the closed-chamber technique were as follows. (1) N2O emission varied widely among the fertilized control areas without urine, and when a threshold water-filled pore space >60% was exceeded, the greater the topsoil nitrate content the greater the flux from the individual urine patches on the fertilized swards. (2) After urine application in May, 1.4-4.2% of the applied urine-N was lost as N2O from the fertilized swards; and after urine application in September, 0.3-0.9% of the applied urine-N was lost. The primary influence on N2O flux from urine patches was the date of simulated grazing, N-fertilization rate being a secondary influence. (3) The large differences in N2O emissions between unfertilized and fertilized swards after May-applied urine contrasted with only small differences after urine applied in September, indicating an interaction between time of urine application and N-fertilizer rate. (4) The estimated annual N2O emissions were in the range 0.6-1.6 kg N2O-N per livestock unit, or 1.4, 3.6, 4.1 and 5.1 kg N2O-N ha-1 from the 0-360 kg ha-1 of fertilizer-N. The study demonstrated that date of grazing and N-fertilizer application could influence the N2O emission from urine patches to such an extent that both factors should be considered in detailed large-scale estimations of N2O fluxes from grazed grassland. [ABSTRACT FROM AUTHOR]

Published
2003
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40. N2 O-Freisetzung auf gemähtem Dauergrünland in Abhängigkeit von Standort und N-Düngung.

Author

Hoffmann, Ch., Anger, M., and Kühbauch, W.

Subjects
*NITROUS oxide, *FERTILIZERS, *GLOBAL warming, *OZONE layer
Abstract

N[sub 2]O Emissions from True Meadows Dependent on Location and N Fertilization Agricultural production is thought to be a main anthropogenic emitter of nitrous oxide (N[sub 2]O), which contributes to global warming and the destruction of the ozone layer. There is still considerable uncertainty about the amount of N[sub 2]O emission, and the site-specific parameters that affect N[sub 2]O emission. From October 1995 until March 1998 experiments were conducted at established field plots (true meadows) at three different sites, i.e. low mountain range (Eifel), lowland (Niederrhein), and moist meadows (Münsterland). Plots were fertilized with calcium ammonium nitrate (CAN) at nitrogen equivalents ranging from 0 to 360 kg N ha[sup -1]. N[sub 2]O fluxes were measured throughout the whole year using the closed-chamber method. In addition, data on temperature, water-filled pore space and precipitation were collected. N[sub 2]O emission rates (rag N[sub 2]O-N ha[sup -1] h[sup -1]) were highest either after fertilizer application or in winter during frost, depending on the experimental site and N dosage. The annual amount of N losses due to N[sub 2]O emission was dependent on the experimental site and the type and dosage of fertilizer. Disregarding the 360 kg N ha[sup -1] level of the CAN treatments, the N losses in this experiment were less than 1.5 kg N[sub 2]O-N ha[sup -1] yr[sup -1]. At low fertilizer dosage there was no reliable correlation between the amount of N that was applied and the amount of N[sub 2]O that was emitted. However, with high fertilizer levels the N[sub 2]O emissions increased gradually. Finally, N[sub 2]O emissions were more influenced by the amount of CAN than by the site. [ABSTRACT FROM AUTHOR]

Published
2001
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42. Atm inactivation results in aberrant telomere clustering during meiotic prophase.

Author

Pandita, T K, Westphal, C H, Anger, M, Sawant, S G, Geard, C R, Pandita, R K, and Scherthan, H

Abstract

A-T (ataxia telangiectasia) individuals frequently display gonadal atrophy, and Atm-/- mice show spermatogenic failure due to arrest at prophase of meiosis I. Chromosomal movements take place during meiotic prophase, with telomeres congregating on the nuclear envelope to transiently form a cluster during the leptotene/zygotene transition (bouquet arrangement). Since the ATM protein has been implicated in telomere metabolism of somatic cells, we have set out to investigate the effects of Atm inactivation on meiotic telomere behavior. Fluorescent in situ hybridization and synaptonemal complex (SC) immunostaining of structurally preserved spermatocytes I revealed that telomere clustering occurs aberrantly in Atm-/- mice. Numerous spermatocytes of Atm-/- mice displayed locally accumulated telomeres with stretches of SC near the clustered chromosome ends. This contrasted with spermatogenesis of normal mice, where only a few leptotene/zygotene spermatocytes I with clustered telomeres were detected. Pachytene nuclei, which were much more abundant in normal mice, displayed telomeres scattered over the nuclear periphery. It appears that the timing and occurrence of chromosome polarization is altered in Atm-/- mice. When we examined telomere-nuclear matrix interactions in spermatocytes I, a significant difference was observed in the ratio of soluble versus matrix-associated telomeric DNA sequences between meiocytes of Atm-/- and control mice. We propose that the severe disruption of spermatogenesis during early prophase I in the absence of functional Atm may be partly due to altered interactions of telomeres with the nuclear matrix and distorted meiotic telomere clustering.

Published
1999

46. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author

P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. Chew Wong, Michael Roppolo, U. Neyer, S. Ahmad, J. Mackie, R. Minasian, M. Verrelli, A. Abukurah, M. Laski, P. Brunet, Madeleine V. Pahl, Daniel Zehnder, E. Alas, Muralidhar Acharya, G. Rudolf, G. Zakar, M. Reddy, R. Specter, G. Grandaliano, I. Kulcsar, A. Amatya, Eugenie Pedagogos, O. Ayodeji, G. Jensen, S. Diamond, Xavier Warling, P. Teredesai, M. Mathew, M. Haque, M. Solis, E. Andrés Ribes, M.A. van den Dorpel, Akhtar Ashfaq, Christian Rabbat, David G. Warnock, M. Sebastian Diaz, C. Mousson, R. Darwish, M. Sperto Baptista, N. Salgado, E. Alvarez Sandoval, M. Vasilevsky, P. Chidester, D. Polack, Simon J. Davies, G. Brosnahan, A. Agarwal, Chaim Charytan, T. Hannedouche, M. Gross, I. Arias, G. James, Jürgen Floege, Tom Dejagere, Patrick S. Parfrey, S. Cournoyer, T. Cavalieri, Gérard M. London, K. Gandhi, A. Kshirsagar, O. Khrustalev, J. Zacharias, Michel Dhaene, Jennifer Tuazon, W. Weise, J. Guzman-Rivera, HS Brink, Alastair J. Hutchison, P. D. Cunha, Robyn G Langham, S. Soman, J. Goldman, S. Kazup Erdelyine, A. Widerhorn, M. Henriquez, N. Hunt, W. Hoerl, O. Arkossy, J. Szegedi, R. Dhingra, M. Fernandez Lucas, Jesus Navarro, A. Kark, Andrey Gurevich, Cynthia J. Brown, Rajnish Mehrotra, L. Kleinman, S. Ferenczi, Loreto Gesualdo, V. Schwenger, M. Ramirez, N. Mittman, Ana María Cusumano, K. Marczewski, Moustafa Moustafa, Sônia M. H. A. Araújo, E. Ladanyi, M. Auricchio, Maurice Laville, P. Urena Torres, C. Gallart, A. Israelit, V. Altobelli, E. Hagen, S. Nosrati, John P. Middleton, Kant Ks, F. Al-Saghir, S. Steinberg, S. Neiva Coelho, Botond Csiky, Philip G Zager, M. Sekkarie, Vanda Jorgetti, Domingos O. d'Avila, Carol A. Pollock, L. Lai, B. von Albertini, Beckie Michael, U. Kunzendorf, N. Frischmuth, A. Durrbach, L. Vasconcellos, Raymond Vanholder, M. Dickenmann, B. Schiller-Moran, Steven D. Soroka, J. Rubin, O. Balkarova, S. Morse, M. Teixeira Araújo, D. Perlin, M. Khan, C. Hura, Dagmar-C. Fischer, D. Machado, Seamas C. Donnelly, D. Sapir, V. Lorica, L. Deboni, M. Jose, M. Galicia, K. Bidas, David Spiegel, David Goldsmith, Peter F Mount, A. Strokov, L. Yu, J. Pitone, Biagio Ricciardi, Alastair Gillies, M. Moyses Neto, Piergiorgio Bolasco, V. Anashkin, John R. Sedor, M. Lee, E.M. Jones, M. Culpepper, G. London, D. Joly, N. Khadikova, Charles A. Herzog, P. Meier, M. Farina, Dana V. Rizk, William M. McClellan, M. Cook, Bastian Dehmel, Patrizia Ferrari, F. Almeida, V. Pogue, R. McCrary, F. Macario, J. Golden, E. Wijeyesinghe, Tilman B. Drüeke, E. Osanloo, M. Muszytowski, F. Arif, Giuseppe Villa, M. Torres Zamora, Steven Zeig, N. Thompson, A. Jamal, C. Sholer, P. Stroumza, D. Reddan, Arun Gupta, J. Montenegro, T. DelGiorno, D. Eadington, G. Shostka, Michel Jadoul, A. Weigert, Sergio Stefoni, P. Dreyer, Carmel M. Hawley, J. Cardeal da Costa, M. Switalski, G. Talaulikar, A. Felsenfeld, J. MacLaurin, T. Herman, N. Pritchard, M. Michaud, K.-U. Eckardt, R. Romero, G. Volgina, Fred E. Husserl, J. Soler Amigó, David S. Goldfarb, A. Matalon, M. D. Torres, P. Sampaio Lacativa, L. Major, U. Lund, A. Lafalla, S. Sarkar, Jennifer M. MacRae, J. Lobo, Liudmila Rozhinskaya, Johann Braun, H. Daugaard, S. Khokhar, S. Rubinstein, D. Bhatia, G. Timokhovskaya, T. Wooldridge, A. Voßkühler, Nelson Kopyt, Pablo E. Pergola, Michel Burnier, L. Samuels, J. Alcázar de La Ossa, J. Billiouw, R. Liebl, P. Sidhu, S. Menahem, P. Montambault, E. Schwertfeger, K. Staroselsky, J. Kovarik, S. Horn, N. Tareen, Simon D. Roger, Francesco Locatelli, Kenneth W. Mahaffey, J Vanwalleghem, Robert I. Lynn, M. Prados, K. Kapatkin, N. Peñalba, Kailash Jindal, M. Stegman, R. Stahl, Joseph A. Eustace, S. Desmeules, A. Hazzan, D. Scott, B. Taparia, G. Keightley, P. Jensen, V. Ortalda, K. McConnell, Alejandro Martin-Malo, Margaret M. Williams, Stuart M. Sprague, S. Chow, Diego Brancaccio, Yumi Kubo, P. Dykes, E. de Francesco Daher, C. Erley, Joanna Matuszkiewicz-Rowińska, T. Minga, I. Dasgupta, Galen S. Wagner, N. Marchetta, R. Rigolosi, P. Raguram, P. Lang, P. Cambier-Dwelschauwers, A. Tsang, M. Schonefeld, W. Bentkowski, Z. Sharon, Daniel Batlle, James T. McCarthy, M. Vital Flores, M. Rambausek, A. Zemtchenkov, Fabio Malberti, V. Thakur, O. Domashenko, D. Wheeler, J. Capelli, Bernard Jones, D. Uehlinger, K. Olgaard, K. Lhotta, M. Bernardo, S. Goldberger, Alison Thomas, E. Dunnigan, A. Ksiazek, A. Assefi, C. Poole, G. Rosa Diez, G. Newman, J. Cotton, C. Combe, B. Murthyr, Sharon M. Moe, H. Neumayer, J. Mittleman, Robert G. Fassett, W. Cleveland, F. van der Sande, C. Vela, H. Fessi, J. Robertson, Giuseppe Cannella, Bryan N. Becker, João M. Frazão, V. Shilo, M. Rano, J. De Meester, R. Fiedler, J. Floege, B. Murray, Giovambattista Capasso, F. Dellanna, J. Luiz Gross, K. Tucker, C. Santiago, Paul J. Martin, M. Nowicki, L. Friedman, William G. Goodman, G. Diez, Markus Ketteler, S. Arfeen, I. Mezei, J. Ortiz, Elizabeth E. Brown, Deborah Zimmerman, Aleix Cases, M. El Khatib, Martine Leblanc, R. Daelemans, K. Malireddi, C. Rikker, R. Gladish, F. Aranda Verástegui, R. Kopelman, B. Borbas, J. Buerkert, K. Ntoso, J. Peña, V. Garcia, C. West, M. Azer, J. Kwan, J. Sterrett, P. Swift, A. Raff, R. Kohli, S. Lew, Steven J. Rosansky, H. Graf, K. Bouman, F. Skinner, C. Tielemans, S. Ferreira Filho, Jocemir Ronaldo Lugon, M. Weinberg, Parfrey, P. S., Drueke, T. B., Block, G. A., Correa-Rotter, R., Floege, J., Herzog, C. A., London, G. M., Mahaffey, K. W., Moe, S. M., Wheeler, D. C., Kubo, Y., Dehmel, B., Goodman, W. G., Chertow, G. M., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo de Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., de Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., de Almeida Romao, E., Cardeal da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., London, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., van den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., van der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., 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Subjects
Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract

Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814

Published
2015

47. Promoting Data Sharing: The Moral Obligations of Public Funding Agencies.

Author

Wendelborn C, Anger M, and Schickhardt C

Subjects
Humans, Research Support as Topic ethics, Cooperative Behavior, Information Dissemination ethics, Moral Obligations, Ethics, Research
Abstract

Sharing research data has great potential to benefit science and society. However, data sharing is still not common practice. Since public research funding agencies have a particular impact on research and researchers, the question arises: Are public funding agencies morally obligated to promote data sharing? We argue from a research ethics perspective that public funding agencies have several pro tanto obligations requiring them to promote data sharing. However, there are also pro tanto obligations that speak against promoting data sharing in general as well as with regard to particular instruments of such promotion. We examine and weigh these obligations and conclude that all things considered funders ought to promote the sharing of data. Even the instrument of mandatory data sharing policies can be justified under certain conditions., (© 2024. The Author(s).)

Published
2024
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48. Early onset of APC/C activity renders SAC inefficient in mouse embryos.

Author

Horakova A, Konecna M, Radonova L, and Anger M

Abstract

Control mechanisms of spindle assembly and chromosome segregation are vital for preventing aneuploidy during cell division. The mammalian germ cells and embryos are prone to chromosome segregation errors, and the resulting aneuploidy is a major cause of termination of development or severe developmental disorders. Here we focused on early mouse embryos, and using combination of methods involving microinjection, immunodetection and confocal live cell imaging, we concentrated on the Spindle Assembly Checkpoint (SAC) and Anaphase Promoting Complex/Cyclosome (APC/C). These are two important mechanisms cooperating during mitosis to ensure accurate chromosome segregation, and assessed their activity during the first two mitoses after fertilization. Our results showed, that in zygotes and 2-cell embryos, the SAC core protein Mad1 shows very low levels on kinetochores in comparison to oocytes and its interaction with chromosomes is restricted to a short time interval after nuclear membrane disassembly (NEBD). Exposure of 2-cell embryos to low levels of spindle poison does not prevent anaphase, despite the spindle damage induced by the drug. Lastly, the APC/C is activated coincidentally with NEBD before the spindle assembly completion. This early onset of APC/C activity, together with precocious relocalization of Mad1 from chromosomes, prevents proper surveillance of spindle assembly by SAC. The results contribute to the understanding of the origin of aneuploidy in early embryos., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Horakova, Konecna, Radonova and Anger.)

Published
2024
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49. Chromosome Division in Early Embryos-Is Everything under Control? And Is the Cell Size Important?

Author

Horakova A, Konecna M, and Anger M

Subjects
Animals, Female, Humans, Aneuploidy, Mammals genetics, Cell Size, Chromosomes, Embryonic Development genetics, Chromosome Segregation
Abstract

Chromosome segregation in female germ cells and early embryonic blastomeres is known to be highly prone to errors. The resulting aneuploidy is therefore the most frequent cause of termination of early development and embryo loss in mammals. And in specific cases, when the aneuploidy is actually compatible with embryonic and fetal development, it leads to severe developmental disorders. The main surveillance mechanism, which is essential for the fidelity of chromosome segregation, is the Spindle Assembly Checkpoint (SAC). And although all eukaryotic cells carry genes required for SAC, it is not clear whether this pathway is active in all cell types, including blastomeres of early embryos. In this review, we will summarize and discuss the recent progress in our understanding of the mechanisms controlling chromosome segregation and how they might work in embryos and mammalian embryos in particular. Our conclusion from the current literature is that the early mammalian embryos show limited capabilities to react to chromosome segregation defects, which might, at least partially, explain the widespread problem of aneuploidy during the early development in mammals.

Published
2024
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50. German funders' data sharing policies-A qualitative interview study.

Author

Anger M, Wendelborn C, and Schickhardt C

Subjects
Policy, Qualitative Research, Information Dissemination, Organizations
Abstract

Background: Data sharing is commonly seen as beneficial for science but is not yet common practice. Research funding agencies are known to play a key role in promoting data sharing, but German funders' data sharing policies appear to lag behind in international comparison. This study aims to answer the question of how German data sharing experts inside and outside funding agencies perceive and evaluate German funders' data sharing policies and overall efforts to promote data sharing., Methods: This study is based on sixteen guided expert interviews with representatives of German funders and German research data experts from stakeholder organisations, who shared their perceptions of German' funders efforts to promote data sharing. By applying the method of qualitative content analysis to our interview data, we categorise and describe noteworthy aspects of the German data sharing policy landscape and illustrate our findings with interview passages., Results: We present our findings in five sections to distinguish our interviewees' perceptions on a) the status quo of German funders' data sharing policies, b) the role of funders in promoting data sharing, c) current and potential measures by funders to promote data sharing, d) general barriers to those measures, and e) the implementation of more binding data sharing requirements., Discussion and Conclusion: Although funders are perceived to be important promoters and facilitators of data sharing throughout our interviews, only few German funding agencies have data sharing policies in place. Several interviewees stated that funders could do more, for example by providing incentives for data sharing or by introducing more concrete policies. Our interviews suggest the academic freedom of grantees is widely perceived as an obstacle for German funders in introducing mandatory data sharing requirements. However, some interviewees stated that stricter data sharing requirements could be justified if data sharing is a part of good scientific practice., Competing Interests: The authors do not have any competing interests. This study is part of a research project which is funded by the German Federal Ministry of Education and Research and reports to the project execution organisation DLR Projektträger. Both organisations were part of our larger field of study (German funders) but had no influence on the design or content of this study. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Anger et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2024
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